CONSTELLATION CATHETERS, MODEL 8039— 510(k) K992777

Unknown

Boston Scientific Corp

FDA 510(k) clearance K992777 for CONSTELLATION CATHETERS, MODEL 8039, Unknown on 1999-11-12. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 1999-08-18
Decision date: 1999-11-12
Decision: Unknown
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MTD

product code MTD

Death: 22
Injury: 376
Malfunction: 986
Total: 1,384

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.